The Contact-CTI Study: Use of Tissue Contact Data to Guide Atrial Flutter Ablation

Atrial Flutter Clinical Trial

Official title:

The Contact-CTI Study - Does Assessment of Tissue Contact During Ablation of Atrial Flutter Improve Outcomes?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596959
• Other study ID #: 79426/244082/1/568
• Secondary ID: 11/SC/0394
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2012
• Last updated: October 11, 2017
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2012
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be a single blind prospective randomised control trial in patients undergoing ablation for the treatment of typical atrial flutter, with the aim of investigating the benefit of a new impedance-based computer software application which measures tissue contact between the ablation catheter and the inside of the heart.

The investigators hope to demonstrate that the use of this tissue contact information reduces ablation time, Xray time, and procedure time required to complete the procedure successfully. Study participants will be randomly assigned to undergo their procedure with or without this contact data displayed for the doctor performing the ablation to see. The acute procedural endpoint of ablation is successful conduction block across the cavotricuspid isthmus of the right atrium. If the outcome of this study is positive, it will have a significant beneficial impact on this procedure, reducing procedure length, patient discomfort, and potentially reducing risk for the patient, recurrent arrythmia symptoms, and the need for repeat procedures later on.

Description:

Patients in this study will be de novo cases of atrial flutter ablation, and they will be randomised to ablation using tissue contact data provided by the St. Jude medical ECI technology (active arm), or standard ablation as per physician practice, without the use of contact data to guide ablation (control arm). The endpoint measures will include RF ablation time, procedure time, time to achieving cavotricuspid isthmus block, the need for "touch up" ablation to achieve conduction block, the recurrence rate of isthmus conduction on isuprel infusion at 20 minutes post-isolation, and clinical recurrence of atrial flutter post-operatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is undergoing de novo cavotricuspid isthmus ablation.

2. Participant is willing and able to give informed consent for participation in the study.

3. Male or Female, aged 18 years or over

Exclusion Criteria:

(1) Previous percutaneous or open surgical procedure involving the right atrium

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Procedure:
• Radiofrequency ablation utilising the ECI contact software
irrigated radiofrequency ablation to the right atrium using the ECI contact data
• Radiofrequency ablation without the use of ECI contact data
irrigated RF ablation without the use of ECI contact data

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Headington	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is the mean ablation time required to achieve the acute procedural endpoint of cavotricuspid isthmus conduction block		immediate (intra-procedural)